Kenyan Health Patient Information Leaflet
Therapeutic agent (verify pharmacological class)
INDICATIONS AND USAGE Levobunolol hydrochloride ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension.
DOSAGE AND ADMINISTRATION The recommended starting dose is one to two drops of levobunolol hydrochloride ophthalmic solution, 0.5% in the affected eye(s) once a day. In patients with more severe or uncontrolled glaucoma, levobunolol hydrochloride ophthalmic solution, 0.5% can be administered twice a day. As with any new medication, careful monitoring of patients is advised. Dosages above one drop of levobunolol hydrochloride ophthalmic solution, 0.5% twice a day are not generally more effective. If the patient's IOP is not at a satisfactory level on this regimen, concomitant therapy with other ophthalmic IOP-lowering agents can be instituted. Patients should not typically use two or more topical ophthalmic beta-adrenergic blocking agents simultaneously.
ADVERSE REACTIONS In clinical trials the use of levobunolol hydrochloride ophthalmic solution has been associated with transient ocular burning and stinging in up to 1 in 3 patients, and with blepharoconjunctivitis in up to 1 in 20 patients. Decreases in heart rate and blood pressure have been reported (see CONTRAINDICATIONS and WARNINGS ). The following adverse reactions have been reported rarely with the use of levobunolol hydrochloride ophthalmic solution: iridocyclitis, headache, transient ataxia, dizziness, lethargy, urticaria, and pruritus. Decreased corneal sensitivity has been noted in a small number of patients. Although levobunolol has minimal membrane-stabilizing activity, there remains a possibility of decreased corneal sensitivity after prolonged use. The following additional adverse reactions have been reported either with levobunolol hydrochloride ophthalmic solution or ophthalmic use of other beta-adrenergic receptor blocking agents: BODY AS A WHOLE: Headache, asthenia, chest pain. CARDIOVASCULAR: Bradycardia, arrhythmia, hypotension, syncope, heart block, cerebral vascular accident, cerebral ischemia, congestive heart failure, palpitation, cardiac arrest. DIGESTIVE: Nausea, diarrhea. PSYCHIATRIC: Depression, confusion, increase in signs and symptoms of myasthenia gravis, paresthesia. SKIN: Hypersensitivity, including localized and generalized rash, alopecia, Stevens-Johnson Syndrome. RESPIRATORY: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion. UROGENITAL: Impotence. ENDOCRINE: Masked symptoms of hypoglycemia in insulin-dependent diabetics (see WARNINGS ). SPECIAL SENSES: Signs and symptoms of keratitis or eye allergy, blepharoptosis, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, ptosis, and foreign body sensation in eye. Other reactions associated with the oral use of non-selective adrenergic receptor blocking agents should be considered potential effects with ophthalmic use of these agents. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
HOW SUPPLIED Levobunolol hydrochloride ophthalmic solution USP, 0.5% is supplied sterile in a plastic bottle with a controlled drop tip in the following sizes: NDC 24208-505-05 - 5 mL NDC 24208-505-10 - 10 mL NDC 24208-505-15 - 15 mL Storage: Store between 15°C to 25°C (59°F to 77°F). Protect from light. Replace cap immediately after use. KEEP OUT OF REACH OF CHILDREN. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2022 Bausch & Lomb Incorporated or its affiliates Revised: October 2022 9117404 (Folded) 9117504 (Flat) Do not